BPC December 29 update

​Cempra (CEMP) shares collapse 57% on CRL; Innocoll (INNL) receives Refusal to File letter - shares down 49%

Price and Volume Movers

Cempra, Inc. (Nasdaq:CEMP) shares tumbled to close down 57% to $2.60 on 14x average volume following notification that it received a Complete Response Letter (CRL) from the FDA in regard to its New Drug Applications (NDAs) for oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

A safety trial of approximately 9,000 patients will need to be conducted together with resolving all manufacturing facility deficiencies before the NDAs can be approved.

Innocoll (NASDAQ:INNL) shares have slumped 49% in the after-hours session to $0.90 following its announcement that it received a Refusal to File letter from the FDA for its NDA of XARACOLL for the treatment of postsurgical pain. The company stated:

“In the Refusal to File letter, the FDA indicated among other things, that XARACOLL should be characterized as a drug/device combination, which would require that the Company submit additional information.  The company will request a Type A meeting with the FDA to respond to several issues believed to be addressable and seek clarification of what additional information, if any, will be required.  Additional details will be disclosed in the future after discussions with the FDA.”

Apollo Endosurgery announced that it has completed its merger transaction with Lpath, Inc. (Nasdaq: LPTN) and will begin trading on the NASDAQ Global Market under the ticker ‘APEN’ on December 30, 2016.

Shares of Protalix Biotherapeutics Inc (NYSEMKT:PLX) closed up 19% to $0.46 on 4x average volume. The company is due to release interim data from its Phase 2 trial of AIR DNase (PRX-110) for the treatment of Cystic Fibrosis (CF) during the first week of January 2017.

Other major price movers (+10%):


Fortress Biotech Inc (NASDAQ:FBIO): $2.77; +21%; 70x average volume.

Capricor Therapeutics Inc (NASDAQ:CAPR): $2.93; +12%.

ADMA Biologics Inc (NASDAQ:ADMA): $5.29; +10%; 4x average volume.


Galena Biopharma Inc (NASDAQ:GALE): $2.05; -14%; 2.5x average volume.

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP): $0.47; -10%; 1.5x

Cleveland BioLabs, Inc. (NASDAQ:CBLI): $1.37; -10%; 3x average volume.

Today will be the final daily issue of the BioPharmCatalyst Daily Newsletter for 2016 with the next issue due out on January 2, 2017, the first trading day of the new year. The new year will bring a number of new tools to assist with investing in biotech stocks. Details to come during 1Q 2017.

Full pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

Solithera - oral
Community-acquired bacterial pneumonia (CABP)

CRL CRL announced December 29, 2016. Further trials required.

Solithera - intravenous
Community-acquired bacterial pneumonia (CABP)

CRL CRL announced December 29, 2016. Further trials required.

Post-operative pain

NDA Filing Refusal to file letter received December 29, 2016. Intends to initiate short-term Pharmacokinetic study and several short-term non-clinical studies before resubmitting NDA filing in late 2017.

Anabasum (Resunab)
Cystic Fibrosis

Phase 2 Phase 2 data released March 30, 2017 - primary endpoint met but some concerns regarding efficacy.