Amicus up on preliminary Q3 results

Amicus Therapeutics (NASDAQ:FOLD) expects Galafold sales in Q3 to be ~$48M, up 133% from a year ago and above consensus of ~$45M.

It is raising the lower end of its full-year range for Galafold sales to $170M – 180M from $160M – 180M. It expects to end the year with more than $420M in cash which should extend its runway into H1 2022.

The webcast of its Analyst Day is currently underway.

Shares up 6% premarket on light volume.

https://seekingalpha.com/news/3504981-amicus-6-percent-premarket-preliminary-q3-results

OncoSec up after strategic deal for TAVO and VLA

OncoSec Medical (NASDAQ:ONCS) is up 34% premarket on entering into a strategic transaction with Grand Decade Developments Limited, a direct, wholly-owned subsidiary of China Grand Pharmaceutical and Healthcare Holdings, and its affiliate, Sirtex Medical US Holdings.

OncoSec will receive a $30M investment from CGP and Sirtex at $2.50/share.

Upon the closing of this transaction, CGP and Sirtex together will hold 53% of OncoSec common shares and will be entitled to three of nine seats on the OncoSec Board of Directors.

OncoSec will grant Grand Decade and its affiliates an exclusive license to develop, manufacture, commercialize, or otherwise exploit OncoSec’s current and future products, including TAVO and OncoSec’s new Visceral Lesion Applicator (VLA), in Greater China and 35 other Asian countries (the “Territory”).

Grand Decade will pay up to 20% royalties on the net sales of such products in the Territory.

Sirtex will support and assist OncoSec with pre-marketing activities for TAVO and VLA in exchange for low single-digit royalties.

https://seekingalpha.com/news/3504997-oncosec-plus-34-percent-premarket-strategic-deal-tavo-vla

BioNTech prices initial public offering

BioNTech SE (BNTX) has priced its initial public offering of 10M American Depositary Shares, each representing one ordinary share at $15.00 per ADS, for gross proceeds of $150M.

Underwriters over-allotment is an additional 1.5M ADSs.

The ADSs are expected to begin trading today on the Nasdaq Global Select Market.

The offering is expected to close on October 15.

Previously: BioNTech readies IPO (Oct. 9)

https://seekingalpha.com/news/3504901-biontech-prices-initial-public-offering

UCB agrees to buy Ra Pharma for $2.5B

UCB SA (OTCPK:UCBJF) has agreed to acquire Ra Pharmaceuticals (NASDAQ:RARX) for $48 per share in cash or $2.5B (€2.2B)($2.1B net of RARX cash).

UCB says the deal is consistent with its “Accelerate and Expand” strategy. In this case, it gains access to RA’s zilucoplan, in Phase 3 development for myasthenia gravis (MG), complementing its own rozanolixizumab, also in late-stage development for MG.

Zilucoplan is also being evaluated in other complement-mediated disorders like ALS and immune-mediated necrotizing myopathy.

The transaction will not affect UCB’s 2019 financial guidance. It will be dilutive to its mid-term earnings and will extend its mid-term goal of EBITDA/revenue of 31% out one year to 2022.

The deal should close by the end of Q1 2020.

RARX is up 106% premarket on light volume.

https://seekingalpha.com/news/3504914-ucb-agrees-buy-ra-pharma-2_5b

ProQR’s sepofarsen shows positive action in Phase 1/2 study in LCA10

ProQR Therapeutics (NASDAQ:PRQR) announces positive topline results from a Phase 1/2 clinical trial evaluating sepofarsen (QR-110) in patients with Leber congenital amaurosis type 10 (LCA10) due to a certain mutation in the CEP290 gene.

The target dose (80 µg with a 160 µg loading dose) was associated with a clinically meaningful and statistically significant improvement in vision with a favorable benefit/risk profile. Durable improvements in vision were observed after six months of treatment.

A Phase 2/3 trial is in process.

Management will host a conference call this morning at 8:00 ET to discuss the results.

Shares are up 7% premarket on light volume.

https://seekingalpha.com/news/3504920-proqrs-sepofarsen-shows-positive-action-phase-1-2-study-lca10

Mednax to sell MedData business to Frazier Healthcare

Mednax (NYSE:MD) has entered into a definitive agreement wit Frazier Healthcare Partners under which the company will sell its MedData business to Frazier.

Under the terms of the purchase agreement, MD will receive cash consideration of ~$250M at closing, as well as economic consideration of up to $50M contingent upon short and long-term performance of MedData.

MEDNAX also anticipates certain cash tax benefits from the transaction in the coming quarters.

Net proceeds from the sale will be used for debt repayment, share repurchases and strategic acquisitions.

The transaction is expected to close during Q4 2019.

https://seekingalpha.com/news/3504932-mednax-sell-meddata-business-frazier-healthcare

Emergent Bio gets PRIME designation for chikungunya virus VLP vaccine candidate

The Committee for Medicinal Products for Human Use (CHMP) of the EMA grants Emergent BioSolutions’ (NYSE:EBS) chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate, CHIKV VLP, PRIority MEdicines, or PRIME, designation.

PRIME Designation allows for frequent and early interactions with the EMA aimed at supporting accelerated evaluation and approval.

The company expects to initiate a pivotal trial in 2020.

https://seekingalpha.com/news/3504938-emergent-bio-receives-prime-designation-chikungunya-virus-vlp-vaccine-candidate