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The Daily Biotech Pulse: Merrimack Pulls The Plug On Early-Stage Trial, Legal Headache For Novartis-Amgen Migraine Partnership

Shanthi Rexaline

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

Scaling The Peaks

(Biotech stocks hitting 52-week highs on April 4)

  • AEterna Zentaris Inc. (NASDAQ: AEZS)
  • GALAPAGOS NV/S ADR (NASDAQ: GLPG)
  • Krystal Biotech Inc (NASDAQ: KRYS)
  • Millendo Therapeutics Inc (NASDAQ: MLND)
  • Orchard Therapeutics PLC – ADR (NASDAQ: ORTX)

Down In The Dumps

(Biotech stocks hitting 52-week lows on April 4)

  • Avadel Pharmaceuticals PLC (NASDAQ: AVDL)
  • Evoke Pharma Inc (NASDAQ: EVOK)
  • Opiant Pharmaceuticals Inc (NASDAQ: OPNT)
  • Pluristem Therapeutics Inc. (NASDAQ: PSTI) (announced stock and warrant offering)
  • Viveve Medical Inc (NASDAQ: VIVE)

Stock In Focus Merrimack Halts Early-Stage Solid Tumor Drug Study

Merrimack Pharmaceuticals Inc (NASDAQ: MACK) said it's discontinuing the development of MM-310, its antibody-directed nanotherapeutic for the treatment of solid tumors, following a comprehensive review of available safety data from a Phase 1 study. The company also said it will initiate workforce reduction as it closes out clinical activities.

Incidentally, the company has already embarked on the exploration of strategic alternatives.

The stock slumped 13.77 percent to $6.20 in after-hours trading.

Acceleron Discontinues Neuromuscular Disorder Drug Study

Acceleron Pharma Inc (NASDAQ: XLRN) announced the discontinuation of the development of ACE-2494, a systemic muscle agent it had been studying in a Phase 1 healthy volunteer trial for the potential treatment of neuromuscular disorders.

"Although ACE-2494 showed promising early signs of target engagement in our recently completed Phase 1 trial, the frequency of anti-drug antibodies (ADAs) observed among participants has led us to discontinue the program," the company said.

The stock fell 4.02 percent to $44.40 in after-hours trading.

See Also: Attention Biotech Investors: Mark Your Calendar For These April PDUFA Dates

Novartis, Amgen In Legal Tussle Over Termination Of Migraine Collaboration Agreement

Novartis AG (NYSE: NVS) said Amgen, Inc. (NASDAQ: AMGN) issued a notice of termination of the collaboration agreement it had with the former related to migraine drug development. Novartis said it disputes the notice vigorously and has filed a lawsuit asking the court to confirm Amgen has no rights to terminate the deal.

"The agreements will remain in force unless and until a final and binding court decision is pronounced that terminates the agreements," Novartis said.

Incidentally, the combo's CGRP-based migraine therapy Aimovig 70mg or 140mg, to be administered as a once-monthly self-injection using Amgen's SureClick autoinjector was approved by the FDA in May 2018.

Axovant Announces 1-For-8 Reverse Stock Split

Axovant Sciences Ltd (NASDAQ: AXGT) said its board and a majority of its shareholders have approved a reverse stock split in the ratio 1-for-8, which is expected to become effective in May 2019. The proposed stock split will reduce the number of outstanding common shares from 182.2 million to about 22.8 million, the company said.

Axovant also announced the closing of the public offering of common shares in March for gross proceeds of $40 million.

The stock slid 5.60 percent to $1.18 in after-hours trading.

Vital Therapies Announces Shareholder Approval For Reverse Merger With Immunic

Vital Therapies Inc (NASDAQ: VTL) said its stockholders voted to approve the proposals to consummate the previously-announced business combination with privately-held German biotech Immunic AG at a special meeting of its shareholders held Thursday.

As per an earlier agreement, boards of both companies approved the business combination, which is likely to be completed by mid-April. Pursuant to the completion of the merger, Vital Therapies will change its name to Immunic and the shares will commence trading on the Nasdaq under the ticker symbol IMUX.

The stock rallied 24.34 percent to 26 cents in after-hours trading.

Syros Announces Common Stock and Preferred Stock Offering

Syros Pharmaceuticals Inc (NASDAQ: SYRS) said it is offering to sell common stock and Class A warrants to purchase common stock, and shares of its Series A convertible preferred stock and Class A warrants to purchase common stock, in two concurrent but separate underwritten public offerings.

The stock plunged 17.95 percent to $8 in after-hours trading.

Zealand Pharma Announces New CEO

ZEALAND PHARMA/S ADR (NASDAQ: ZEAL) announced the appointment of pharma industry veteran Emmanuel Dulac as its CEO, effective April 22. He will replace Adam Steensberg, who has held the CEO role on an interim basis.

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