Harriet Lefton

About the Author Harriet Lefton

Harriet originates from the UK where she worked as a journalist specializing in the metal markets. She graduated from the University of Cambridge before becoming a qualified UK lawyer.

Monday’s Biotech Insights: Pulmatrix Inc (PULM), Regulus (RGLS), Ocera Therapeutics (OCRX)

Pulmatrix Inc (NASDAQ:PULM) shares are trading sharply down by 26% after the company announced that it had signed a definitive agreement with several investors for a direct offering valued up to roughly $5 million. The offering, which is expected to close on Feb 2 2017, sees the pharma company, which develops inhaled therapies for pulmonary disease, sell approx. 2 million shares for $2.5 a share. The market is disappointed by the sale which significantly undervalues PULM- the company apparently had a $50 million market cap before the sale was announced.

Regulus Therapeutics Inc (NASDAQ:RGLS) shares are sinking by 50% in Monday’s trading session after the company announced that it has received notice from the FDA that the clinical development program for RG-101, a hepatitis C drug, remains on clinical hold. In June 2016, RG-101 was placed on clinical hold following the company’s submission of a second serious adverse event (SAE) of jaundice. The FDA has now requested the final safety and efficacy data from ongoing RG-101 studies before reconsidering the clinical hold- this data should be available in the fourth quarter according to Regulus.

“While we are disappointed that the clinical hold was not lifted at this time, we plan to continue to work with the FDA to address their additional requests as we seek the removal of the clinical hold,” said Dr. Timothy Wright, Chief R&D Officer of Regulus.

Out of the 7 analysts who published recommendations on Regulus in the last three months, 3 rate the stock a buy and 4 rate the stock a hold. There are no sell recommendations. The average analyst price target of $8.75 is now an incredible 629% upside from the current share price of $1.20.

Ocera Therapeutics Inc (NASDAQ:OCRX) shares have crashed by 70% so far in Monday’s trading session with trading volumes also up following the announcement that in its Phase 2b clinical trial for its leading pipeline drug OCR-002 failed to beat the placebo in two key endpoints. The first endpoint measured time to improvement in hepatic encephalopathy (HE) symptoms, the second endpoint measured time to complete response in HE symptoms. On the plus side, OCR-002-treated patients showed a statistically valid reduction in the time to achieve normal plasma ammonia levels versus placebo. OCRX still plans to advance OCR-002 into Phase 3 development.


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