Search This Blog

Monday, November 11, 2019

Foamix to merge with Menlo Therapeutics

Foamix Pharmaceuticals (NASDAQ:FOMX) and Menlo Therapeutics (NASDAQ:MNLO) have signed a definitive merger agreement to create a combined biopharmaceutical company focused on the commercialization and development of therapeutics to serve patients in the dermatology space.
The combined company will have a diversified portfolio including an approved product and three late-stage product candidates focused on dermatologic indications. The transaction is structured as a stock-for-stock exchange.
Under the terms of the merger agreement, each share of Foamix stock will be exchanged for 0.5924 of a share of Menlo common stock and a contingent stock right (“CSR”).
Foamix and Menlo shareholders will own ~59% and ~41%, respectively, of the combined company on a pro forma, fully diluted basis.
The combined company will be led by David Domzalski, CEO of Foamix and headquartered in New Jersey.
The transaction is expected to be completed in late Q1/early Q2 of 2020.
Posted by at No comments:

Amicus +6% premarket on Q3 beat

Amicus Therapeutics (FOLD) Q3 results: Revenues: $48.8M (+136.9%).
Net loss: ($61.8M) (+61.2%); loss/share: ($0.24) (+71.4%); Quick Assets: $514.2M (+2.0%).
2019 guidance: Galafold revenue: $170M – 180M from $160M – 180M.
Key Strategic Priorities: Complete enrollment in Phase 3 PROPEL clinical study in Pompe disease and report additional Phase 2 data.
Report additional two-year results from Phase 1/2 clinical study in CLN6 Batten disease and complete enrollment in ongoing CLN3 Batten disease Phase 1/2 study.
Shares are up 6% premarket.
Previously: Amicus Therapeutics EPS beats by $0.08, beats on revenue (Nov. 11)
Posted by at No comments:

FDA rejects Lipocine’s Tlando application again; shares down 69% premarket

Lipocine (NASDAQ:LPCN) has received a second Complete Response Letter (CRL) from the FDA regarding its refiled marketing application for testosterone replacement therapy candidate Tlando.
This time the agency cited one issue (instead of four the first time): the efficacy trial failed to meet the three secondary endpoints for maximal testosterone concentrations (Cmax).
The company intends to request a meeting with the agency to clarify a path forward.
The company received the first CRL in May 2018.
Posted by at No comments:

Invitae to acquire Clear Genetics for $50M

Invitae (NYSE:NVTA) has will acquire genetic services software developer Clear Genetics for ~$50M.
Under the terms of the agreement, NVTA will pay ~$25M in cash and the rest in shares of common stock. The transaction should close in the next few days.
Posted by at No comments:

Nektar up 5% premarket on encouraging NKTR-358 data

Nektar Therapeutics (NASDAQ:NKTR) perks up 5% premarket on light volume in reaction to final results from a Phase 1a clinical trial evaluating the safety and tolerability of NKTR-358 in 100 healthy volunteers. The data, a continuation of the results presented at EULAR in June, were presented at the American College of Rheumatology Annual Meeting in Atlanta.
NKTR-358 was safe and well-tolerated with no anti-drug antibodies detected. Pharmacokinetics were dose-proportional.
Ascending doses led to sustained increases in FoxP3+CD25bright Treg cells, immune cells that can prevent the activation of T cells in autoimmune disorders, without any measurable changes in CD4+ and CD9+ T cells.
The company refers to NKTR-358 as a resolution therapeutic that may bring the immune system back into balance by activating regulatory T cells via targeting the interleukin (IL-2) receptor complex in the body.
It is developing the candidate with collaboration partner Eli Lilly (NYSE:LLY) under a 2017 agreement.
Posted by at No comments:

Analyst action, Nov. 11

AcelRx Pharmaceuticals (NASDAQ:ACRX) downgraded to Neutral with a $2 (3% upside) price target at Credit Suisse. Shares down 3% premarket.
CytomX Therapeutics (NASDAQ:CTMX) downgraded to Neutral with an $8 (34% upside) price target at Wedbush. Shares down a fraction premarket.
Wright Medical Group (NASDAQ:WMGI) downgraded to Neutral with a $31 (5% upside) price target at Baird.
Posted by at No comments:

NextCure down 53% premarket on NC318 data

Thinly traded NextCure (NASDAQ:NXTC) is down 53% premarket on modest volume on the heels of updated results from the first part of its Phase 1/2 clinical trial evaluating NC318, a Siglec-15 (S15)-targeting monoclonal antibody, in patients with solid tumors. The data were presented at the SITC Annual Meeting in Maryland.
Seven dose cohorts (8 mg – 1,600 mg every two weeks) were assessed, predominantly in patients with non-small cell lung cancer (n=13), ovarian cancer (n=7), melanoma (n=7), breast cancer (n=4) and colorectal cancer (n=3). All NSCLC patients failed to respond to PD-1 inhibitor treatment (median of four prior lines of therapy).
Durable responses were observed, including one complete response (ongoing at week 55), one partial response (ongoing at week 28), four NSCLC patients with stable cancer (ongoing at weeks 16 – 40) and 14 participants overall with stable cancer (ongoing at weeks 16 – 42).
On the safety front, 15 patients remain on study implying a discontinuation rate as high as 44% (n=15/34). Most treatment-emergent adverse events (TEAEs) were mild/moderate. There were three serious TEAEs, one case of episcleritis/uveitis and two cases of pneumonitis.
The company has initiated the Phase 2 portion which will evaluate 400 mg administered every two weeks in ~100 patients with NSCLC, ovarian, head and neck and triple-negative breast cancers. The primary endpoints are safety and tolerability. Secondary endpoints include efficacy measures. Preliminary data should be available by late Q4 2020.
Shares tripled last week ahead the data.
Posted by at No comments:
Subscribe to: Comments (Atom)