Ragothaman Srinivasan - Spark Newswire

1 minute read

Biomea Fusion Commences Initial-Stage Study For Plasma Cell Cancer Setting

Today, 5:37 AM

Biomea Fusion (NASDAQ: BMEA) has dosed the the first patient in the multiple myeloma (MM) cohort of the Phase I clinical trial evaluating BMF-219, a covalent menin inhibitor. Multiple myeloma (MM) is a cancer of plasma cells, which make antibodies (immunoglobulins) and are mainly located in the bone marrow.

BMEA

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Krystal Biotech Files To Seek Approval For Skin Disease Candidate

By Ragothaman Srinivasan

Today, 5:37 AM

Krystal Biotech, Inc. (NASDAQ: KRYS) submits biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of B-VEC (beremagene geperpavec) in the treatment of patients with dystrophic epidermolysis bullosa (DEB).

KRYS

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Mustang Bio Shares Gain As FDA Grants Orphan Drug Status To Waldenstrom Drug

By Ragothaman Srinivasan

Today, 5:37 AM

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Mustang Bio’s (NASDAQ: MBIO) lead drug MB-106 for the treatment of Waldenstrom macroglobulinemia (WM), a rare type of B-cell non-Hodgkin lymphoma (B-NHL).

MBIO

3 minute read

Recap of Tuesday’s Biotech Catalysts – End of the Day Summary

By Ragothaman Srinivasan

Today, 5:37 AM

Ionis (NASDAQ: IONS) announced that Eplontersen met co-primary and secondary endpoints in interim analysis of the Phase 3 NEURO-TTRansform study for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) Ionis shares are trading low 4 percent at $35.10 in the after-hours session

ABBV

1 minute read

Paratek Pharmaceuticals’ Shares Gain Following FDA Fast Track Designation For Nontuberculous Mycobacterial (NTM) Drug

By Ragothaman Srinivasan

Today, 5:37 AM

Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) received Fast Track designation from the U.S.

PRTK

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Acer Therapeutics’ Stock Down As FDA Rejects Inborn Metabolism Disorder (UCD) Candidate

By Ragothaman Srinivasan

Today, 5:37 AM

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to Acer Therapeutics’ (NASDAQ: ACER) New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension in the treatment of patients with urea cycle disorders (UCDs).

ACER

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Nuvectis Pharma Gets FDA Nod For Initial-Stage Ovarian Cancer Study

By Ragothaman Srinivasan

Today, 5:37 AM

The U.S. Food and Drug Administration (FDA) cleared Nuvectis Pharma’s (NASDAQ: NVCT) Investigational New Drug Application (IND) for NXP800, which includes the Phase 1 clinical trial protocol.

NVCT

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Regulus Gets FDA Orphan Drug Status For Kidney Disease Candidate

By Ragothaman Srinivasan

Today, 5:37 AM

Regulus Therapeutics Inc. (NASDAQ: RGLS) received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its lead drug RGLS8429 in the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

RGLS

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VYNE Therapeutics Concludes Patient Enrolment in Mid-Stage Study Of Skin Inflammation Candidate

By Ragothaman Srinivasan

Today, 5:37 AM

VYNE Therapeutics Inc. (NASDAQ: VYNE) has concluded patient enrollment in the Phase 2a study of of its drug candidate FMX114 for the treatment of mild-to-moderate atopic dermatitis (AD).

VYNE

1 minute read

FDA
News

Kazia Therapeutics’ Shares Gain Following FDA Orphan Drug Status For Childhood Brain Cancer Drug

By Ragothaman Srinivasan

Today, 5:37 AM

The United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Kazia Therapeutics’ (NASDAQ: KZIA) Paxalisib for the treatment of atypical rhabdoid / teratoid tumors (AT/RT), a rare and highly-aggressive childhood brain cancer.

KZIA