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The Daily Biotech Pulse: Regulatory Roadblock For Immunomedics, AdCom Split On Lexicon's Diabetes Drug

The Daily Biotech Pulse: Regulatory Roadblock For Immunomedics, AdCom Split On Lexicon's Diabetes Drug

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peak

(Biotech stocks hitting 52-week highs on Jan. 17)

  • Avenue Therapeutics Inc (NASDAQ: ATXI)
  • BioSpecifics Technologies Corp. (NASDAQ: BSTC)
  • Regeneron Pharmaceuticals Inc (NASDAQ: REGN)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Jan. 17)

  • Amneal Pharmaceuticals Inc (NYSE: AMRX)
  • Avrobio Inc (NASDAQ: AVRO)
  • Neuronetics Inc (NASDAQ: STIM)
  • Sesen Bio Inc (NASDAQ: SESN)

Stock In Focus

FDA Panel Divided On Lexicon-Sanofi's Diabetes Drug

Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) said the FDA's Endocrinology and Metabolic Advisory Committee voted 8 to 8 on whether the benefit-risk profile supports the approvability of Sotagliflozin, which it co-develops with Sanofi SA (NASDAQ: SNY).

Sotagliflozin is an investigational oral dual SGLT1 and SGLT2 inhibitor being reviewed as an adjunct to insulin for treating adults with Type 1 diabetes.

The stock plunged 22.08 percent to $6 in after-hours trading.

FDA Issues Complete Response Letter For Immunomedics' Breast Cancer Drug

Immunomedics, Inc. (NASDAQ: IMMU) said the FDA has handed down a complete response letter for its BLA for Sactuzumab Govitecan, its investigational candidate for metastatic triple-negative breast cancer, or TNBC, in patients who have previously received at least two prior therapies.

"The issues related to approvability in the CRL were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need to be generated," the company said.

Zymeworks To Get $8M in Milestone Payment from Eli Lilly Following IND Filing

Zymeworks Inc (NYSE: ZYME) said partnerEli Lilly And Co (NYSE: LLY) has filed a second investigational new drug application, or IND, for an immuno-oncology bispecific antibody enabled by Zymeworks' proprietary Azymetric platform.

Based on the licensing and collaboration agreement between both companies, with the achievement of this milestone, Zymeworks stands to receive $8 million.

The stock rallied 5.39 percent to $13 in after-hours trading.

See Also: The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trials

J&J Unit Advances Pipeline Candidate For Ulcerative Colitis Developed Using Morphosys' Technology

MORPHOSYS AG/S ADR (NASDAQ: MOR) said Johnson & Johnson (NYSE: JNJ)'s Janssen unit has initiated a proof-of-concept Phase 2a trial to evaluate its Guselkumab developed using Morphosys' proprietary HuCAL antibody technology, which is being studied for moderately to severely active ulcerative colitis.

Aratana Promotes Craig Tooman To The Role of CEO

Aratana Therapeutics Inc (NASDAQ: PETX), which develops therapeutics for pets, announced the appointment of Craig Tooman as CEO. Tooman earlier served as Chair of Aratana's Audit Committee before taking over a CFO.

Common Stock Offerings

Bio-Path Holdings Inc (NASDAQ: BPTH) announced the closing of its previously announced underwritten public offering of 8.59 million shares to the public at a price of 13 cents per share. The company said it mobilized gross proceeds of $1.1 million from the offering.

The stock climbed 7.06 percent to 14 cents in after-hours trading.

Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) said it intends to offer its common stock and Series E Convertible Preferred Stock in underwritten public offerings.

"Sunesis anticipates using the net proceeds from the proposed offerings to fund ongoing development of vecabrutinib, ongoing research and development, debt amortization, and general corporate purposes," the company said.

The stock slumped 11.67 percent to 52 cents in after-hours trading.

Kindred Biosciences Inc (NASDAQ: KIN) said it proposed a public offering of its common stock. All the shares are to be offered by the company.

On The Radar

Clinical Trial Results

The following companies are scheduled to release clinical trials at 2019 ASCO Gastrointestinal Cancers Symposium, held between Jan.17 and Jan. 19, in San Francisco, California:

Rexahn Pharmaceuticals, Inc. (NYSE: RNN) will present updated Phase 2 data for its RX-3117, in combination with Abraxane, which is being evaluated as first-line treatment for pancreatic cancer.

TRACON Pharmaceuticals Inc (NASDAQ: TCON) is due to present full Phase 2 data for TRC105 and Nexavar, in hepatocellular carcinoma.

ASLAN PHARMACEU/ADR (NASDAQ: ASLN) is expected to present new Phase 1/2 data for its Varlitinib + gemcitabine and cisplatin, being tested for biliary tract cancer.

Tyme Technologies Inc (NASDAQ: TYME) will present interim Phase 2 data for its pancreatic cancer treatment candidate SM-88.


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