Kadmon Holdings Inc. (NYSE:KDMN) raised $75 million through the sale of 6.3 million shares at $12 in an IPO underwritten by Citigroup, Jefferies, JMP Securities and H.C. Wainwright. The IPO price values the company at $538.4 million. Kadmon shares are to begin trading Wednesday.
Earlier this month, Kadmon said it hoped to sell 5.6 million shares at $16-$20. The company filed in June to raise up to $140 million.
Kadmon's most advanced programs, autoimmune and fibrotic disease candidate KD025 and oncology therapy tesevatinib (XL647), are both in Phase II testing. KD025 is an oral selective inhibitor of Rho-associated coiled-coil containing protein kinase 2 (ROCK2). Tesevatinib is a tyrosine kinase inhibitor (TKI) that targets EGFR, VEGF receptor 2 (VEGFR-2; KDR/Flk-1), HER2 and Src.
Gilead Sciences Inc. (NASDAQ:GILD) fell $7.50 to $81.05 on Tuesday, shedding about $10 billion in market cap. On Monday after market close, it lowered its 2016 guidance and reported 2Q16 earnings showing that its HCV sales have slowed (see BioCentury Extra, July 25).
Gilead is off 33% from its 52-week high of $120.37, reached Aug. 4, 2015.
Newron Pharmaceuticals S.p.A. (SIX:NWRN) said FDA will not require the company to conduct clinical studies of Parkinson's disease candidate Xadago safinamide to study its dependence and withdrawal effects or abuse liability. Newron said it had submitted relevant data to the agency after the company received a complete response letter for Xadago in March (see BioCentury Extra, March 29).
Newron said it expects to resubmit its NDA for Xadago by November. The CRL did not require additional data related to safety or efficacy of the candidate, which was under review as an add-on therapy for early and mid to late stage PD.
Xadago is an alpha-aminoamide derivative that acts as a reversible monoamine oxidase B (MAO-B) and dopamine reuptake inhibitor while reducing glutamatergic activity.
Newron gained CHF1.55 to CHF18.50 on Tuesday.
Genmab A/S (CSE:GEN) said FDA granted Darzalex daratumumab breakthrough therapy designation in combination with Revlimid lenalidomide and dexamethasone as a second-line treatment for multiple myeloma.
The human IgG1k mAb against CD38 has accelerated approval from FDA to treat MM in patients who have failed at least three prior therapies, including a proteasome inhibitor (PI) and an immunomodulatory agent. Darzalex has breakthrough therapy designation in that indication as well.
Johnson & Johnson (NYSE:JNJ) has worldwide rights to Darzalex under a 2012 deal. J&J did not respond to inquiries about submitting Darzalex to regulators as a second-line MM therapy. Celgene Corp. (NASDAQ:CELG) markets Revlimid.
Genmab gained DKK65 to DKK1,210 on Tuesday.
Luye Pharma Group Ltd. (HKSE:2186) is to acquire the transdermal drug delivery systems (TDS) business from delivery play Acino Holding AG (Aesch, Switzerland) for EUR 245 million ($268.6 million). Luye said it sees "substantial growth potential" from the TDS business' products and pipeline, which include specialty patches in CNS and pain. Luye also said the acquisition is part of its international expansion strategy.
Tokai Pharmaceuticals Inc. (NASDAQ:TKAI) fell $4.10 (79%) to $1.10 on Tuesday after it said it would stop the Phase III ARMOR3-SV study of galeterone (TOK-001) to treat metastatic castration-resistant prostate cancer (CRPC). Tokai said an independent DMC determined the study is unlikely to meet its primary endpoint of improving radiographic progression-free survival (rPFS) vs. Xtandi enzalutamide.
The study enrolled treatment-naive patients whose tumors express androgen receptor splice variant 7 (AR-V7). Tokai plans to present ARMOR3-SV data in a scientific forum.
Tokai intends to evaluate an ongoing expansion arm of its Phase II ARMOR2 study of galeterone in metastatic CRPC patients with an acquired resistance to Xtandi, as well as a planned study of galeterone in patients who rapidly progress on prostate cancer drugs Xtandi or Zytiga abiraterone.
Galeterone is an oral selective androgen receptor modulator (SARM) and cytochrome P450 17 alpha-hydroxylase/C17, 20 lyase (CYP17; CYP17A) inhibitor.
Tokai's next most advanced compound is in preclinical development, and is based on the company's androgen receptor degradation agents (ARDA) discovery platform. At June 30, the company had $43.9 million in cash. Its market cap sank below $25 million on Tuesday.
Medivation Inc. (NASDAQ:MDVN) and Astellas Pharma Inc. (Tokyo:4503) share rights to Xtandi. Johnson & Johnson (NYSE:JNJ) markets Zytiga.
Moderna Therapeutics Inc. (Cambridge, Mass.) and AstraZeneca plc (LSE:AZN; NYSE:AZN) said the pharma filed a clinical trial application to start a Phase I study of AZD8601, an mRNA-based therapy that encodes VEGF-A for cardiometabolic diseases.
AstraZeneca and Moderna began a five-year deal in 2013 to discover, develop and commercialize mRNA therapeutics for cancer, cardiovascular, metabolic and renal diseases. The program would be the first under that deal to reach the clinic.
Earlier this month, Moderna told BioCentury it plans to reveal more information about its mRNA platform now that it has begun a clinical study of lead program mRNA 1440. The mRNA vaccine against an undisclosed viral target is unpartnered (see BioCentury, July 18).
Exact Sciences Corp. (NASDAQ:EXAS) gained $3.75 (30%) to $16.21 on Tuesday after reporting 2Q16 revenues of colorectal cancer test Cologuard that beat expectations, and a narrower than expected loss per share in the quarter.
Revenues in 2Q16 were $21.2 million, up 43% sequentially from $14.8 million in 1Q16 and ahead of analysts' $18.5 million consensus. Revenues were also up from $8.1 million in 2Q15. The company said it completed about 54,000 Cologuard tests during 2Q16, compared to about 40,000 in 1Q16 and 21,000 tests in 2Q15. Its average recognized revenue per test was $391 in 2Q16.
Exact Sciences' loss per share was $0.46, slightly wider than $0.44 in 2Q15 but narrower than the Street's estimated loss of $0.55.
Cologuard was named in final guidelines on colorectal cancer screening released last month by the U.S. Preventive Services Task Force (USPSTF) (see BioCentury Extra, June 15).
On a conference call Tuesday, President and CEO Kevin Conroy said Exact Sciences believes the guidelines will "position Cologuard to receive the benefits of an A-graded preventive service" under the Affordable Care Act. He said the company expects to see more commercial payers cover Cologuard this half.
Exact Sciences reiterated its full-year revenue guidance of $90-$100 million. On the call, Conroy said the company expects Cologuard's growth to be driven by new physician adoption and increased utilization, and by the potential inclusion of the test in a set of healthcare performance measures from the National Committee for Quality Assurance, an independent accreditation organization.
Cologuard is a non-invasive stool DNA test that uses a multiplexed quantitative Invader assay for the simultaneous detection of methylated and unmethylated sequences in the promoter region of the vimentin (VIM) gene.
Diagnostics company CellMax Life Inc. (Sunnyvale, Calif.) said it raised $9 million in a series A-1 financing led by Artiman Ventures. Taiwanese investors, including Acer Inc. (Taiwan:2353; LSE:ACID) founder Stan Shih, also participated. The company has raised a total of $14 million to date.
Also on Tuesday, CellMax said it had begun marketing CellMax CRC-Protect in Taiwan. The product is a multi-biomarker blood test for early detection of colorectal cancer.
In draft guidance released Tuesday, FDA outlined its thinking on the use of real-world evidence in making regulatory decisions about medical devices. The agency described factors it would consider when evaluating the relevance, reliability and quality of real-world evidence, and suggests when it might use such data to make decisions about devices.
To evaluate the reliability of data, FDA will assess how they were collected, their adequacy for answering relevant questions, and whether they were collected in a manner that minimizes bias. The guidance says a prospective protocol is "essential to ensure reliability" of real-world evidence.
The guidance says FDA might use such evidence to expand a device's approved indications, for postmarket surveillance, and as a control for studies of subsequent devices. Comments on the draft are due Oct. 25.
According to the PDUFA VI agreement goals letter released this month, FDA intends to publish draft guidance by YE21 on how real-world evidence can be used to assess safety and effectiveness in regulatory submissions of drugs. An FDA spokesperson declined to comment on the guidance.
FDA's Center for Devices and Radiological Health also has been in the vanguard of the agency's efforts to solicit patient preference data and use it to support approval decisions. Last year, CDRH used patient preference data to approve the Maestro Rechargeable System from EnteroMedics Inc. (NASDAQ:ETRM) to treat obesity (see BioCentury, Sept. 7, 2015).
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