On Thursday, a few companies in the biotech and pharmaceutical industries made substantial runs. In this case it was all downward, due to the results of U.S. Food and Drug Administration (FDA) approvals, failed or passed trials, public offerings and even earnings results. Below we have included information about each company, as well as recent trading activity and the consensus price target.
After Auris Medical Holding A.G. (NASDAQ: EARS) reported its second-quarter financial results late Wednesday, the stock took a dive. The company posted a net loss of $8.7 million, or $0.26 per share.
At the same time, Auris provided a business update on its acute inner ear tinnitus trial that was not up to par. The company said that it was disappointed in the top-line results from its TACTT2 trial with Keyzilen, and that it will meet with regulatory agencies with further analysis in the fourth quarter.
Auris shares were last seen down 60% at $2.16 on Thursday, with a consensus analyst price target of $9.75 and a 52-week trading range of $1.95 to $7.96.
Portola Pharmaceuticals Inc. (NASDAQ: PTLA) announced that it has received a Complete Response Letter (CRL) from the FDA in regards to its Biologics License Application for AndexXa (andexanet alfa).
Currently, AndexXa is an FDA-designated Breakthrough Therapy that is in development for patients treated with a direct (apixaban, rivaroxaban, or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Currently there is no FDA-approved antidote for this.
For those that don’t know, a CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form. Sometimes this can be a death sentence for a drug.
Shares of Portola were trading down 19% at $19.17, with a consensus price target of $40.20 and a 52-week range of $18.20 to $57.96.
The top-line results from Cerulean Pharma Inc.’s (NASDAQ: CERU) mid-stage clinical trial of its lead candidate, CRLX101, in combination with Avastin (bevacizumab)m in the treatment of patients with advanced renal cell carcinoma, demonstrated no statistically significant difference in median progression-free survival and objective response rate for the CRLX101. Christopher D. T. Guiffre, president and CEO of Cerulean, further commented:
We are disappointed with this outcome and will undertake a thorough analysis of the data to understand why CRLX101 plus Avastin underperformed compared to the results we saw in an earlier investigator-sponsored trial.
Shares of Cerulean were down 61% at $1.06. The consensus price target is $8.71, and the 52-week range is $0.95 to $5.20.
After the markets closed on Wednesday Juniper Pharmaceuticals Inc. (NASDAQ: JNP) announced that it did not achieve its primary and secondary endpoints in a mid-stage trial. The company’s Phase 2b clinical trial is evaluating its 10% lidocaine bioadhesive vaginal gel, COL-1077, for the reduction of pain intensity in women undergoing an endometrial biopsy with tenaculum placement. Based on the results of the trial, the company decided to discontinue its development of COL-1077.
Juniper shares were down 24% at $5.41, with a consensus price target of $16.67 and a 52-week range of $4.30 to $15.44.
OncoMed Pharmaceuticals Inc. (NASDAQ: OMED) just announced the pricing of a secondary offering for a total of 5.5 million shares, with an overallotment option for an additional 825,000 shares. The offering is being priced at $10 per share, valuing the entire offering up to $65.25 million. Keep in mind that the company has a market cap of roughly $300 million. Also the company is offering these shares at a discount of 18% from its 50-day moving average of $12.22.
Shares of OncoMed traded down 15% at $9.95 apiece, with a consensus price target of $18.14 and a 52-week range of $8.42 to $23.98.