Type

Oncolytics Biotech® Reports First Quarter 2024 Financial Results and Operational Highlights

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Giovedì, Maggio 9, 2024
Breast cancer, FDA, Cancer, SCCA, Paclitaxel, FOLFIRINOX, International, Pancreatic cancer, Research, Thought, Immunotherapy, Breast, TSX, PR, AB, Conference, ONC, ASCO, TIL, Anal canal, Patient, Society, Pancreatic Cancer Action Network, Anal, Ethics, Annual general meeting, Pelareorep, Type, Anal cancer, CGMP, Medical imaging

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Key Points: 
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    SAN DIEGO and CALGARY, AB, May 9, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced recent operational highlights and financial results for the first quarter ended March 31, 2024.
  • General and administrative expenses for the first quarter of 2024 were $3.0 million, compared to $3.2 million for the first quarter of 2023.
  • Research and development expenses for the first quarter of 2024 were $5.7 million, compared to $3.5 million for the first quarter of 2023.
  • The net loss for the first quarter of 2024 was $6.9 million, compared to a net loss of $6.4 million for the first quarter of 2023.

Anika Reports First Quarter 2024 Financial Results

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Mercoledì, Maggio 8, 2024
FDA, Anika, Surgeon, Elective surgery, PEEK, Webcast, EPS, Therapy, Type, Growth, Video game

BEDFORD, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company in early intervention orthopedics, today reported financial results for its first quarter ended March 31, 2024.

Key Points: 
  • Revenue up 7% on growing demand and favorable order timing; On-track for 2024 revenue guidance
    Cost reduction initiatives complete; On-track to achieve 2024 adjusted EBITDA guidance of $25-30 million, up over 75% at the midpoint
    BEDFORD, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company in early intervention orthopedics, today reported financial results for its first quarter ended March 31, 2024.
  • Revenue in the first quarter of 2024 was $40.5 million, up 7% compared to $37.9 million in the first quarter of 2023.
  • As such, Anika expects revenue for fiscal year 2024 of $168 to $173 million, representing growth of 1% to 4% compared to 2023.
  • Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights today, Wednesday, May 8, 2024, at 5:30 pm ET.

Aquestive Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update

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Martedì, Maggio 7, 2024
Angioedema, FDA, Mouth, NDA, Food, Swelling, Skin, Research, Attention deficit hyperactivity disorder, Insurance, Trial of the century, ADHD, Lennox–Gastaut syndrome, Dermatology, Seizure, Prescription, Public expenditure, Riluzole, Vomiting, Patent, Patient, Adrenaline, Common stock, Anaphylaxis, Epilepsy, Diazepam, PD, Therapy, Serdexmethylphenidate/dexmethylphenidate, Type, Pharmaceutical industry

“We continue to successfully execute on our growth strategy as demonstrated by our first quarter results,” said Daniel Barber, Chief Executive Officer of Aquestive.

Key Points: 
  • “We continue to successfully execute on our growth strategy as demonstrated by our first quarter results,” said Daniel Barber, Chief Executive Officer of Aquestive.
  • Total revenues increased to $12.1 million in the first quarter 2024 from $11.1 million in the first quarter 2023.
  • Research and development expenses increased to $5.9 million in the first quarter 2024 from $3.5 million in the first quarter 2023.
  • Non-GAAP adjusted EBITDA loss was $7.2 million in the first quarter 2024, compared to non-GAAP adjusted EBITDA loss of $3.9 million in the first quarter 2023.

Top Five Cancer Types Dominate New US Cases as Biotech Sector Eyes $314B Market by 2032

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Venerdì, Maggio 3, 2024
PFS, United Nations, FDA, Mutation, Daiichi Sankyo, Pancreatic cancer, Bio-Rad Laboratories, MBC, ONC, Prostate cancer, Paper, Behavior, Breast cancer, AstraZeneca, Paclitaxel, Fast track (FDA), Woman, TSX, CELC, DdPCR, Oncolytics Biotech, Ageing, Therapy, Pelareorep, Combination therapy, Combination, Mutant, Survival, Research, Cancer, MRD, Progression-free survival, Marketing, Immunotherapy, AHN, PCR, United, Patient, Type, Pharmaceutical industry

VANCOUVER, BC, May 3, 2024 /PRNewswire/ -- According to a "highly troubling" new study, the rising number of cancer cases in young people is being attributed to "accelerated aging." Further alarm is being spread by the United Nations, whose health authorities are predicting global cancer cases to rise around 77% by 2050, with richer countries expected to have the greatest absolute increase in cancer, with an additional 4.8 million new cases predicted in 2050. With the global cancer immunotherapy market projected by analysts at Custom Market Insights to reach US$314.4 billion by 2032, growing at a 7.2% CAGR, the biotech sector continues to make significant developments in cancer treatment and diagnostics, with recent updates coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), Bio-Rad Laboratories, Inc. (NYSE: BIO), and AstraZeneca PLC (NASDAQ: AZN).

Key Points: 
  • "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.
  • Oncolytics Biotech requested to meet with the FDA in Q2 2024 to finalize the registrational trial design and objectives for using pelareorep to treat metastatic breast cancer.
  • "These data underscore the potential for treatment with ENHERTU across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer."

Top Five Cancer Types Dominate New US Cases as Biotech Sector Eyes $314B Market by 2032

Retrieved on: 
Venerdì, Maggio 3, 2024
PFS, United Nations, FDA, Mutation, Daiichi Sankyo, Pancreatic cancer, Bio-Rad Laboratories, MBC, ONC, Prostate cancer, Paper, Behavior, Breast cancer, AstraZeneca, Paclitaxel, Fast track (FDA), Woman, TSX, CELC, DdPCR, Oncolytics Biotech, Ageing, Therapy, Pelareorep, Combination therapy, Combination, Mutant, Survival, Research, Cancer, MRD, Progression-free survival, Marketing, Immunotherapy, AHN, PCR, United, Patient, Type, Pharmaceutical industry

VANCOUVER, BC, May 3, 2024 /PRNewswire/ -- According to a "highly troubling" new study, the rising number of cancer cases in young people is being attributed to "accelerated aging." Further alarm is being spread by the United Nations, whose health authorities are predicting global cancer cases to rise around 77% by 2050, with richer countries expected to have the greatest absolute increase in cancer, with an additional 4.8 million new cases predicted in 2050. With the global cancer immunotherapy market projected by analysts at Custom Market Insights to reach US$314.4 billion by 2032, growing at a 7.2% CAGR, the biotech sector continues to make significant developments in cancer treatment and diagnostics, with recent updates coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), Bio-Rad Laboratories, Inc. (NYSE: BIO), and AstraZeneca PLC (NASDAQ: AZN).

Key Points: 
  • "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.
  • Oncolytics Biotech requested to meet with the FDA in Q2 2024 to finalize the registrational trial design and objectives for using pelareorep to treat metastatic breast cancer.
  • "These data underscore the potential for treatment with ENHERTU across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer."

As Early-Onset Breast Cancer Cases Soar in North America and EU, Biotech Ramps Up Response

Retrieved on: 
Martedì, Aprile 30, 2024
FDA, Pancreatic cancer, News, Breast, Fulvestrant, Fast track (FDA), ONC, MBC, PFE, Classification, ICE3, Breast cancer, Paclitaxel, Learning, Kidney, Woman, Economics, Hand, Traction, TSX, Optimism, Eli Lilly and Company, Patient satisfaction, Proteolysis, Freezing, Survival, NEO, Marketing, Clinical trial, CDK, University, Progression-free survival, Recurrence, Disease, Chimera, Patient, Liver, Neoplasm, Type, Growth, Pharmaceutical industry

VANCOUVER, BC, April 30, 2024 /PRNewswire/ -- USA News Group – An alarming rise in early-onset cancers has medical experts very concerned, as cancer cases in younger people are rising sharply. In particular, a surge in cases of breast cancer is being witnessed in Canada, the USA, and the EU, with extra concern to patients thought to be in remission contracting breast cancer a second time, according to a new study from the University of Cambridge. However, there's still optimism towards new treatments, and significant growth of 9.3% CAGR in the metastatic HR+/HER2- breast cancer market through 2032 has treatment developers working harder to make gains for patients. Among the biotech companies currently making strides are Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), IceCure Medical Ltd (NASDAQ: ICCM), Atossa Therapeutics, Inc. (NASDAQ: ATOS), Arvinas, Inc. (NASDAQ: ARVN), and Pfizer Inc. (NYSE: PFE) (NEO: PFE).

Key Points: 
  • Recently, Oncolytics announced that they had submitted a Type C meeting request to the FDA to discuss a forthcoming trial for pelareorep aimed at treating HR+/HER2- metastatic breast cancer (mBC) patients.
  • "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.
  • The company looks forward to meeting with the FDA in Q2 2024 to finalize the trial design and goals for using pelareorep in treating metastatic breast cancer.

As Early-Onset Breast Cancer Cases Soar in North America and EU, Biotech Ramps Up Response

Retrieved on: 
Martedì, Aprile 30, 2024
FDA, Pancreatic cancer, News, Breast, Fulvestrant, Fast track (FDA), ONC, MBC, PFE, Classification, ICE3, Breast cancer, Paclitaxel, Learning, Kidney, Woman, Economics, Hand, Traction, TSX, Optimism, Eli Lilly and Company, Patient satisfaction, Proteolysis, Freezing, Survival, NEO, Marketing, Clinical trial, CDK, University, Progression-free survival, Recurrence, Disease, Chimera, Patient, Liver, Neoplasm, Type, Growth, Pharmaceutical industry

VANCOUVER, BC, April 30, 2024 /PRNewswire/ -- USA News Group – An alarming rise in early-onset cancers has medical experts very concerned, as cancer cases in younger people are rising sharply. In particular, a surge in cases of breast cancer is being witnessed in Canada, the USA, and the EU, with extra concern to patients thought to be in remission contracting breast cancer a second time, according to a new study from the University of Cambridge. However, there's still optimism towards new treatments, and significant growth of 9.3% CAGR in the metastatic HR+/HER2- breast cancer market through 2032 has treatment developers working harder to make gains for patients. Among the biotech companies currently making strides are Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), IceCure Medical Ltd (NASDAQ: ICCM), Atossa Therapeutics, Inc. (NASDAQ: ATOS), Arvinas, Inc. (NASDAQ: ARVN), and Pfizer Inc. (NYSE: PFE) (NEO: PFE).

Key Points: 
  • Recently, Oncolytics announced that they had submitted a Type C meeting request to the FDA to discuss a forthcoming trial for pelareorep aimed at treating HR+/HER2- metastatic breast cancer (mBC) patients.
  • "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.
  • The company looks forward to meeting with the FDA in Q2 2024 to finalize the trial design and goals for using pelareorep in treating metastatic breast cancer.

BioXcel Therapeutics Announces Plan for Evaluating BXCL501 in the At-Home Setting to Expand Its Market Potential

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Lunedì, Aprile 22, 2024
FDA, Patient, Dexmedetomidine, Safety, Agitation, Food, Bipolar disorder, Intermittent explosive disorder, Intelligence, Schizophrenia, Medicine, New product development, DSM-IV codes, Therapy, Type, Pharmaceutical industry

NEW HAVEN, Conn., April 22, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced additional details regarding the planned design of its SERENITY At-Home Phase 3 trial*to evaluate BXCL501, the Company’s investigational, proprietary, orally dissolving film formulation of dexmedetomidine, as a potential acute treatment for agitation associated with bipolar disorders or schizophrenia in the home setting. The Company’s plan to conduct this trial using a 120 mcg dose is based on feedback received from the U.S. Food and Drug Administration (FDA) following the recent receipt of agency minutes from the Type C meeting held on March 6, 2024.

Key Points: 
  • The outpatient trial is expected to enroll a total of approximately 200 patients with agitation associated with bipolar disorder or schizophrenia.
  • Patients will self-administer 120 mcg of BXCL501 or placebo when agitation episodes occur over the trial period.
  • The primary objective is safety with efficacy measures as exploratory endpoints to evaluate use in the outpatient setting.
  • A corporate presentation, including information on the SERENITY program, is available on the Investors section of the Company’s website: bioxceltherapeutics.com.

Connect Biopharma Reports Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Martedì, Aprile 16, 2024
SCI, FDA, Congress, American Academy, Investment, RAD, NDA, Insurance, Partnership, Research, Week, Patient, AAD, Atopic dermatitis, Arena Pharmaceuticals, Inflammation, Accounting, Annual general meeting, Asthma, Inflammatory Bowel Diseases, Type, Connect, UC, Pharmaceutical industry

Preclinical immunological characterization of rademikibart (CBP-201), a next-generation human monoclonal antibody targeting IL-4Rα, for the treatment of Th2 inflammatory diseases .

Key Points: 
  • Preclinical immunological characterization of rademikibart (CBP-201), a next-generation human monoclonal antibody targeting IL-4Rα, for the treatment of Th2 inflammatory diseases .
  • Four posters at the 2023 World Congress of Dermatology in July 2023 on data from the initial 16-week treatment period with rademikibart of the pivotal trial in China in patients with moderate-to-severe AD.
  • Connect expects to receive an update from Simcere as early as Q2 2024 on these next steps.
  • Cash, cash equivalents and short-term investments were $118.7 million as of December 31, 2023, compared with $161.9 million on December 31, 2022.

BioXcel Therapeutics Announces TRANQUILITY In-Care Pivotal Phase 3 Trial Plan With BXCL501 for Agitation Associated With Alzheimer’s Dementia

Retrieved on: 
Mercoledì, Aprile 10, 2024
FDA, Dexmedetomidine, Safety, Agitation, Food, Dementia, Intelligence, Live, Patient, AAD, Medicine, New product development, Database, Positive, Therapy, Type, Pharmaceutical industry

NEW HAVEN, Conn., April 10, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced details regarding the planned design of its upcoming TRANQUILITY In-Care Phase 3 trial to evaluate BXCL501, the company’s investigational proprietary, orally dissolving film formulation of dexmedetomidine, as a potential acute treatment for agitation associated with Alzheimer’s dementia (AAD) in the care setting. The Company’s plan to conduct this trial is based on feedback received from the U.S. Food and Drug Administration (FDA), following the recent receipt of minutes from the Type B/Breakthrough Therapy designation meeting held with the agency on February 20, 2024.

Key Points: 
  • “The design of our upcoming TRANQUILITY In-Care trial largely mirrors TRANQUILITY II, which demonstrated positive efficacy and safety results with a 60 mcg dose of BXCL501,” said Vincent O’Neill, M.D., Chief of Product Development and Medical Officer of BioXcel Therapeutics.
  • “We have completed two recent meetings with the FDA on our TRANQUILITY program, and are pleased to have obtained clarity on the next steps for our AAD development path.
  • The trial is expected to enroll patients with episodic agitation, with patients self-administering 60 mcg of BXCL501 or placebo when agitation episodes occur over the trial period.
  • A slide presentation on the TRANQUILITY program is available on the Investors section of the Company’s website: bioxceltherapeutics.com.