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FDA Panel Backs 2 Biosimilars, ALDR Abuzz, MDXG Q2 Revenue Grows 33%


Today's Daily Dose brings you news about Alder's stock offering; FDA panel recommendation of 2 biosimilar candidates; Sangamo's investigational drugs SB-318 and SB-913 getting Fast Track designation; Pfizer's upcoming regulatory catalyst related to its rheumatoid arthritis drug; Mallinckrodt's progress in its CONFIRM trial and MiMedx Group's better-than-expected Q2 revenue.

Read on...

Alder Biopharmaceuticals Inc. (ALDR) announced that underwriters of its previously announced public offering have exercised in full their option to purchase an additional 2.25 million shares of the Company's common stock.

On July 12, 2017, the Company offered to sell 15 million shares of its common stock to the public at a price of $10.00 each, and granted the underwriters a 30-day option to purchase up to 2.25 million additional shares of common stock at the public offering price.

Including the option exercise, total proceeds to Alder from the offering will be approximately $161.5 million, the Company noted. The offering is expected to close on July 18, 2017.

ALDR closed Thursday's trading at $11.95, up 18.02%. In after-hours, the stock was up 5.02% to $12.55.

An FDA panel has voted 17-0, recommending approval of Amgen (AMGN) and Allergan PLC's (AGN) ABP 215, a biosimilar candidate to Avastin.

Roche's Avastin, the first angiogenesis inhibitor to be approved by the FDA in 2004, is indicated for the treatment of metastatic colorectal cancer, non-small cell lung cancer, HER2-negative breast cancer, glioblastoma, renal cell carcinoma and cervical cancer. Avastin generated sales of $6.71 billion for Roche in 2016.

The FDA's final decision on ABP 215 is expected to be announced on September 14, 2017.

AMGN closed Thursday's trading at $175.04, up 1.02%.

CTI BioPharma Corp.'s (CTIC) Marketing Authorization Application for Pacritinib for the treatment of patients with myelofibrosis who have thrombocytopenia has been validated by the European Medicines Agency.

Now that the application has been validated, the centralized review process will be initiated by the EMA's Committee for Medicinal Products for Human Use (CHMP). The CHMP review period is 210 days, excluding question or opinion response periods, after which the CHMP opinion is reviewed by the European Commission, which usually issues a final decision on EU authorization within three months.

CTIC closed Thursday's trading at $3.39, up 1.19%.

Mallinckrodt plc (MNK) has enrolled the 75th subject in its ongoing phase III pivotal trial of Terlipressin in subjects with Hepatorenal Syndrome type 1.

The trial, dubbed CONFIRM, has hereby achieved one quarter of its targeted enrollment. An interim analysis of trial data to assess the safety and efficacy of Terlipressin in study subjects will be completed when 150 subjects are enrolled and this also marks the halfway point toward that milestone.

Steven Romano, Chief Scientific Officer and Executive Vice President at Mallinckrodt, said, "We are pleased to reach this important milestone in the Terlipressin CONFIRM trial, and look forward to learning more about how the drug can help patients with this serious condition."

MNK closed Thursday's trading at $44.59, up 1.11%.

MiMedx Group Inc.'s (MDXG) revenue for the second quarter of 2017 has come in above its guidance range.

The Company's revenue for the recent second quarter is $76.4 million, which has exceeded its guidance range of $73.5 to $75.0 million. The consensus revenue forecast among analysts polled by Thomson Reuters is $74.22 million.

The Q2, 2017 revenue represents 33% increase over the Q2, 2016 revenue.

Commenting on the results, Bill Taylor, President and COO, said, "We are in a very good position in terms of year-to-date revenue performance as we move into the third quarter, which is typically one of our strongest quarters of the year. We had very solid revenue performance during the second quarter, and we are building momentum for a strong showing in the second half of the year and the delivery of a robust year overall."

MDXG closed Thursday's trading at $14.46, down 3.28%.

Mylan N.V. (MYL) and Biocon Ltd.'s proposed biosimilar Trastuzumab has unanimously won the backing of the FDA's Oncologic Drugs Advisory Committee, which voted 16-0 recommending approval.

MYL-1401O is a proposed biosimilar to Roche's breast cancer med Herceptin.

In March of this year, Roche provided a global license for Mylan to commercialize biosimilar Herceptin in various markets around the world. In return, Mylan agreed to withdraw its pending Inter Partes Review (IPR) challenges against two U.S. Genentech patents.

Roche's Herceptin recorded sales of about $6.7 billion last year.

The FDA's final decision date on MYL-1401O is set for September 3, 2017.

If approved, MYL-1401O will be the first Herceptin biosimilar to secure the FDA nod.

MYL closed Thursday's trading at $39.05, up 1.22%. In after-hours, the stock was up another 2.43% to $40.00.

Pfizer Inc's (PFE) supplemental New Drug Application for XELJANZ as a treatment for adult patients with moderately to severely active ulcerative colitis has been accepted for review by the FDA, with a decision to be announced in March 2018.

XELJANZ is already approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis. The drug generated global sales of $927 million in 2016, up 77% compared to 2015.

PFE closed Thursday's trading at $33.28, up 0.18%.

Sangamo Therapeutics Inc.'s (SGMO) clinical stage in vivo genome editing product candidates SB-318 and SB-913, for the treatment of Mucopolysaccharidosis Type I (MPS I) and MPS II, respectively, have been granted Fast Track designation by the FDA.

SB-318 and SB-913 are under phase 1/2 clinical trials in adults with MPS I and MPS II, respectively. The trials are open and subjects are being screened for enrollment.

SGMO closed Thursday's trading at $9.50, up 2.70%.

by RTTNews Staff Writer

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