Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Pfizer Announces Positive Results From Second Late-Stage Study Of Ulcerative Colitis Drug
Pfizer, Inc. PFE announced positive top-line results from a second Phase 3 study of etrasimod, which is being developed for the treatment of moderately to severely active ulcerative colitis. The positive 12- and 52-week results from ELEVATE UC 52 follow the recent announcement of positive 12-week findings from the ELEVATE UC 12 trial on March 23.
Neurocrine's Japanese Partner Gets Approval For Former's Drug To Treat Side Effects Of Antipyschotic Medications
Neurocrine Biosciences, Inc. NBIX announced that its collaboration partner Mitsubishi Tanabe Pharma Corporation obtained regulatory approval of Dysval capsules 40 mg (valbenazine) for the treatment of tardive dyskinesia from the Japanese Ministry of Health, Labour and Welfare on Tuesday.
NeoGenomics CEO Mark Mallon Departs, Company Warns Of Q1 Shortfall, Withdraws FY22 Guidance
NeoGenomics, Inc. NEO announced that its board and chief executive officer Mark Mallon have agreed Mallon will step down from the position and as a member of the board effective immediately. This mutual agreement was not the result of any disagreements about strategy with management or the board, inappropriate action by the CEO, or any violation of company policy or any accounting irregularity, the company said.
The company also said it currently expects its first-quarter revenues to come in below the low-end of its prior guidance of $118 million-$120 million and EBITDA will be below the low end of its prior guidance a negative $12 million to a negative $15 million. The larger than anticipated EBITDA loss was primarily driven by higher than anticipated clinical services cost of goods sold.
NeoGenomics also withdrew its 2022 annual financial guidance issued February 23.
The stock was slumping 26.7% to $13.04 in premarket trading.
Cullinan Oncology Announces Positive Phase 1/2a Data For Lung Cancer DrugÂ
Cullinan Oncology, Inc. CGEM announced clinical and regulatory updates on its lead program, CLN-081, which is being evaluated in a Phase 1/2a clinical trial in non-small cell lung cancer patients whose tumors harbor epidermal growth factor receptor exon 20 insertion mutations that have progressed on or after prior therapy.
For those receiving a 100mg twice-a-day dose, the confirmed response rate was 41% and no patients experienced grade 3 or greater treatment-related diarrhea or rash.
The Food and Drug Administration has encouraged Cullinan to explore the potential for a food effect on the clinical profile of the 150mg dose. Cullinan said it expects to initiate a pivotal study in the second half of 2022 following the completion of this PK food effect study.
The stock was slipping 5% to $10.64 in premarket trading.
Antares Announces Final FDA Approval For Oral Testosterone Replacement Therapy
Antares Pharma, Inc. ATRS announced the FDA granted final approval for oral testosterone replacement therapy Tlando for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. Tlando was developed by Lipocine, Inc. LPCN, with the company exclusively out-licensing the U.S. commercialization rights to Antares.
Sanofi, IGM Strike R&D Collaboration For Developing Antibodies Against Cancer, Inflammatory/Immunology Diseases
Sanofi SNY and IGM Biosciences, Inc. IGMS announced the signing of an exclusive worldwide collaboration agreement to develop, manufacture and commercialize IgM antibody agonists against three oncology targets and three immunology/inflammation targets.
Under the terms of the agreement, IGM will receive a $150-million upfront payment. Sanofi has expressed an interest in purchasing up to $100 million of IGM non-voting common stock in a public financing.
IGM also stands to receive for up to $940 million in development and regulatory milestones per oncology target. For each oncology target, the companies will share profits 50-50 in certain major markets, and IGM will be eligible to receive tiered royalties on net sales in the rest of world.
IGM shares were galloping 41.23% to $21.17 in premarket trading, while Sanofi was slipping 0.46% at $51.59.
ImmunoGen Announces Filing Of Regulatory Application For Ovarian Cancer Treatment
ImmunoGen, Inc. IMGN announced that it has submitted a biologics license application under the accelerated approval pathway to the FDA for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha-high, platinum-resistant ovarian cancer who have been previously treated with one to three prior systemic treatments.
NexImmune Rises On Insider Buying
NexImmune, Inc. NEXI shares advanced after the company disclosed in a filing that Grant Verstandig, a director of the board, acquired 190,600 shares in the company.
The stock was adding 9.88% to $3.56 in premarket trading.
TYME to Explore Strategic Options To Enhance Shareholder Value
TYME Technologies, Inc. TYME announced that its board has decided to explore potential strategic options to enhance stockholder value. The company discontinued its most advanced clinical trial in January. Nevertheless, the biopharma said it believes there are additional opportunities that could enhance value for TYME stockholders.
The stock was moving up 7.91% to 36.99 cents in premarket trading.
Click here to access Benzinga's FDA calendar.
Earnings
Progenity, Inc. PROG reported fourth-quarter revenues of $7.7 million, with $7.2 million of it coming from discontinued operations. Revenues from continuing operations were at $435,000. The net loss per share widened from 46 cents to 56 cents. Analysts, on average, estimated a loss of 16 cents per share.
The stock was slumping 21.12% to $1.27 in premarket trading.
On The Radar
PDUFA Dates
The Food and Drug Administration is scheduled to rule on Akebia Therapeutics, Inc.'s AKBA NDA for vadadustat as a treatment option for anemia in chronic kidney disease patients.
Clinical Readouts/Presentations
Aldeyra Therapeutics, Inc. ALDX will announce at its R&D day top-line data from the Phase 2 proof-of-concept clinical trials of ADX-629 in three types of inflammatory disease, and will discuss new indications selected for clinical development.
Earnings
- SCYNEXIS, Inc. SCYX (before the market open)
- Kala Pharmaceuticals, Inc. KALA (before the market open)
- I-Mab IMAB (before the market open)
- Humacyte, Inc. HUMA (before the market open)
- Ampio Pharmaceuticals, Inc. AMPE (before the market open)
- BioCardia, Inc. BCDA (after the close)
- CorMedix Inc. CRMD (after the close)
- Dyadic International, Inc. DYAI (after the close)
- HTG Molecular Diagnostics, Inc. HTGM (after the close)
- Tricida, Inc. TCDA (after the close)
- OpGen, Inc. OPGN (after the close)
- PAVmed Inc. PAVM (after the close)
- NovaBay Pharmaceuticals, Inc. NBY (after the close)
- Nabriva Therapeutics plc NBRV (after the close)
Related Link: Merck Continues to See Executive Exodus; Here's A Look At All Recent Departures
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