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The Daily Biotech Pulse: Partial Clinical Hold On Advaxis Cervical Cancer Drug, Ohr's Reverse Split, Ironwood Starts Phase 1 Trial

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The Daily Biotech Pulse: Partial Clinical Hold On Advaxis Cervical Cancer Drug, Ohr's Reverse Split, Ironwood Starts Phase 1 Trial

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

No biotech stocks hit 52-week highs Wednesday.

Down In The Dumps

(Biotech stocks hitting 52-week lows on Jan. 23)

  • China SXT Pharmaceuticals Inc (NASDAQ: SXTC)
  • Idera Pharmaceuticals Inc (NASDAQ: IDRA)
  • Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX)
  • Neon Therapeutics Inc (NASDAQ: NTGN)
  • Neuronetics Inc (NASDAQ: STIM)
  • Selecta Biosciences Inc (NASDAQ: SELB)(announced a common stock offering)
  • TIZIANA LF SCIE/S ADR (NASDAQ: TLSA)
  • Tricida Inc (NASDAQ: TCDA)
  • Zafgen Inc (NASDAQ: ZFGN)

Stock In Focus

Advaxis' Cervical Cancer Study Placed On Partial Clinical Hold

Advaxis, Inc. (NASDAQ: ADXS) said the FDA has notified it regarding its Phase 3 study that is evaluating axalimogene filolisbac in high risk advanced cervical cancer being put on partial clinical hold. The company said the partial hold is related to requests for additional information regarding certain AXAL chemistry, manufacturing and controls matter.

The FDA did not raise any safety issues and the currently enrolled patients will continue to receive treatment, as per the trial protocol, the company said. However, the company has been barred from enrolling new patients in AIM2CERV until the resolution of the partial hold.

See Also: Searching For A Treatment: NASH Investigational Drugs With Catalysts This Year

Ironwood's CNS Disorder Drug Enters Clinical Trials

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) said it initiated a Phase 1 study to evaluate its IW-6463 in healthy volunteers. IW-6463 is an orally administered central nervous system, or CNS,-penetrant soluble guanylate cyclase stimulator that is being developed for the treating CNS disorders.

The company said it expects to release data from the study in the second-half of 2019.

Ohr To Implement Reverse Stock Split

OHR Pharmaceutical Inc (NASDAQ: OHRP) said its board has determined to effect a one-for-twenty reverse stock split of its shares. The shares will begin trading on a split-adjusted basis Feb. 4. The reverse split is meant to bring the company into compliance with the minimum bid price requirement for continued listing in the Nasdaq.

"This reverse stock split will help us maintain our NASDAQ listing while we move forward with the process to complete our previously announced merger with NeuBase Therapeutics," said Ohr CEO Jason Slakter.

The stock fell 11.08 percent to 11.07 cents in after-hours trading.

Offerings

Selecta Biosciences priced its public offering of 20 million shares at $1.50 per share.

After shedding 23.63 percent Wednesday, reacting to the announcement concerning the offering, Selecta's shares rose 1.36 percent to $1.49 after-hours trading.

Urogen Pharma Ltd (NASDAQ: URGN) priced its common stock offering of 3.66 million shares at $41 per share compared to the $45.93 at which it closed Wednesday's regular session. The company said the gross proceeds from the offering will be $150 million. After declining 14.41 percent in the regular session on the news of the offering, UroGen shares shed an incremental 6.38 percent in after-hours trading.

Kindred Biosciences Inc (NASDAQ: KIN) closed its public offering of 4.85 million shares of its common stock, which also includes the exercising of options by underwriters to purchase 632,250 additional shares, at $9.50 per share, less underwriting discounts and commissions. The offering fetched the company gross proceeds of $46 million.

Kindred Biosciences shares rose 1.56 percent to $10.10 in after-hours trading.

On The Radar

Earnings

Bristol-Myers Squibb Co (NYSE: BMY) Q4 EPS $0.94 Beats $0.85 Estimate, Sales $5.973B Miss $5.99B Estimate
Meridian Bioscience, Inc. (NASDAQ: VIVO) Q1 EPS $0.20 Beats $0.18 Estimate, Sales $51.48M Miss $53.68M Estimate

Posted-In: Biotech Earnings News Health Care FDA Top Stories Pre-Market Outlook Trading Ideas Best of Benzinga

 

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