Pfenex up on positive human factor data on PF708

Thinly traded micro cap Pfenex (NYSEMKT:PFNX) is up 2% premarket on light volume in response to results from a human factors study that showed the non-inferiority (no worse than) of the user interface of PF708 to Eli Lilly’s (NYSE:LLY) Forteo [teriparatide (rDNA origin) injection].

The company says the data complete the information package required by the FDA to assess the therapeutic equivalence of PF708. Alvogen will manufacture and commercialize in the U.S.

The FDA approved the Forteo biosimilar last week under its 505(b)(2) pathway but requested the human factors study to complete the data package.

https://seekingalpha.com/news/3505486-pfenex-2-percent-premarket-positive-human-factor-data-pf708

Lilly’s Taltz successful in late-stage pediatric psoriasis study

A 201-subject Phase 3 clinical trial, Ixora-peds, evaluating Eli Lilly’s (NYSE:LLY) Taltz (ixekizumab) in children and adolescents aged six to less than 18 years old with moderate-to-severe plaque psoriasis met both co-primary endpoints. The results were presented at the European Academy of Dermatology and Venereology Congress in Madrid.

89% of treated patients achieved at least a 75% improvement from baseline to week 12 in Psoriasis Area and Severity Index score (PASI 75). 81% achieved clear or almost clear skin (static PGA 0,1) at week 12.

All major secondary endpoints were also met. No new safety signals were observed.

Taltz is not yet approved for pediatric use. The FDA OK’d the IL-17A inhibitor for adults with plaque psoriasis in May 2016.

https://seekingalpha.com/news/3505416-lillys-taltz-successful-late-stage-pediatric-psoriasis-study

Flexion down on extension of FDA action date for repeat injections of Zilretta

Flexion Therapeutics (NASDAQ:FLXN) slips 2% premarket on light volume in response to an extension of the FDA’s action date for its review of its application seeking approval for repeat injections of Zilretta (triamcinolone acetonide extended-release injectable suspension) in patients with knee pain due to osteoarthritis. The PDUFA date was today.

The agency has not identified a specific revised action date, but informed the company that its review should be completed in the coming weeks.

Zilretta was first approved in the U.S. in October 2017 (single intra-articular injection).

https://seekingalpha.com/news/3505433-flexion-2-percent-premarket-extension-fda-action-date-repeat-injections-zilretta

Cara to increase enrollment in second late-stage study of Korsuva in CKD-aP

Based on an interim statistical analysis by the Independent Data Monitoring Committee, Cara Therapeutics (NASDAQ:CARA) will boost enrollment by ~20% to 430 subjects in its Phase 3 clinical trial, KALM-2, evaluating KORSUVA (CR845/difelikefalin) in patients on dialysis with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) (itchy skin).

The increase is necessary in order to maintain at least 90% statistical power on the primary endpoint (the proportion of patients achieving at least a three-point improvement in a scale called NRS at week 12).

Enrollment should be completed this quarter. The company still expects to file a U.S. marketing application in H2 2020.

Another Phase 3, KALM-1, was successful.

https://seekingalpha.com/news/3505441-cara-increase-enrollment-second-late-stage-study-korsuva-ckd-ap

Chardan Healthcare amends merger agreement with BiomX

Chardan Healthcare Acquisition (NYSEMKT:CHAC), a special purpose acquisition company (“SPAC”) sponsored by affiliates of Chardan Capital Markets LLC and BiomX Ltd. have entered into an amendment to their definitive agreement.

In connection with the amendment: Investors have committed to an additional purchase of $5M of CHAC shares at $10.35/share.

The minimum closing condition was increased from $50M to $55M of cash in CHAC’s escrow trust account.

The agreement of Chardan Investment to cancel up to 500,000 CHAC shares in the event that the aggregate investment amount is less than $70M was terminated.

https://seekingalpha.com/news/3505452-chardan-healthcare-amends-merger-agreement-biomx

BridgeBio terminates merger process with Eidos

BridgeBio Pharma (NASDAQ:BBIO) announces that it was unable to come to an agreement to acquire the outstanding common stock of its subsidiary Eidos Therapeutics (NASDAQ:EIDX) that BridgeBio does not already own (~34% of Eidos’s outstanding shares).

Subsequent to an initial offer of 1.3 BridgeBio shares for each Eidos share, the offer was raised twice, resulting in a final offer equivalent to 1.5 BridgeBio shares for each Eidos share with an option for Eidos shareholders to receive a portion of that consideration in cash.

https://seekingalpha.com/news/3505455-bridgebio-terminates-merger-process-eidos-therapeutics

FDA OKs new use for J&J’s Xarelto

The FDA approves Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical’s blood thinner XARELTO (rivaroxaban) for the prevention of venous thromboembolism (blood clots) in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.

The new indication is the eighth in the U.S.

Related ticker: Bayer (OTCPK:BAYRY)

https://seekingalpha.com/news/3505463-fda-oks-new-use-j-and-js-xarelto